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國家局7月批準187項進口第一類醫(yī)療器械產(chǎn)品備案
發(fā)布日期:2023-08-03 20:12瀏覽次數(shù):1733次
2023年8月2日，國家藥監(jiān)局發(fā)布進口第一類醫(yī)療器械產(chǎn)品備案數(shù)據(jù)公告，2023年7月，國家局累計批準頸椎固定器、醫(yī)用固定帶、脊柱微創(chuàng)手術(shù)工具包、醫(yī)用檢查手套、下肢醫(yī)用外固定支具、鉆針深度停止器、牙科成形片套裝等187項進口第一類醫(yī)療器械產(chǎn)品備案。一起看正文。

2023年8月2日，國家藥監(jiān)局發(fā)布進口第一類醫(yī)療器械產(chǎn)品備案數(shù)據(jù)公告，2023年7月，國家局累計批準頸椎固定器、醫(yī)用固定帶、脊柱微創(chuàng)手術(shù)工具包、醫(yī)用檢查手套、下肢醫(yī)用外固定支具、鉆針深度停止器、牙科成形片套裝等187項進口第一類醫(yī)療器械產(chǎn)品備案。一起看正文。

進口第一類醫(yī)療器械產(chǎn)品備案.jpg

國家局7月批準187項進口第一類醫(yī)療器械產(chǎn)品備案

序號產(chǎn)品名稱備案號備案人名稱原文生產(chǎn)地址原文備案日期狀態(tài)
1頸椎固定器國械備20170267號?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
2醫(yī)用固定帶國械備20170246號?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
3腰椎固定帶國械備20170245號?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
4腕關(guān)節(jié)固定器國械備20210288號?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland 2023-07-31 變更
5腰部固定器國械備20190176號?ssur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
6肩部固定器國械備20220071號?ssur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
7踝部固定器國械備20220072號?ssur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
8頸部固定器國械備20181375號Ossur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
9胸腰骶固定器國械備20170217號?ssur   hf.Grjóthálsi   1 - 5, IS-110 Reykjavik, Iceland2023-07-31 變更
10下肢醫(yī)用外固定支具國械備20180444號Ossur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
11宮腔活檢鉗國械備20230361號CooperSurgical,   Inc.Industriestr.24   D-78532 Tuttlinger Germany2023-07-31 有效
12醫(yī)用檢查手套國械備20210197號貝格莫特有限公司31,   Jalan Balakong Jaya 4, Taman Industri Balakong Jaya, Seri Kembangan,   Selangor, 43300, Malaysia2023-07-31 變更
13刀頭國械備20200736號ENDOVISION   Co., Ltd.66-26,   Dongnae-ro, Dong-gu. Daegu, Republic of Korea2023-07-28 變更
14脊柱微創(chuàng)手術(shù)工具包國械備20210050號 ENDOVISION Co., Ltd.66-26,   Dongnae-ro, Dong-gu, Daegu, Republic of Korea2023-07-28 變更
15脊柱手術(shù)工具包國械備20200688號ENDOVISION   Co., Ltd.66-26,   Dongnae-ro, Dong-gu, Daegu, Republic of Korea2023-07-28 變更
16種植體安裝輔助器械包國械備20230360號Haenaem   Co., Ltd.194,   Jisan-ro 175beon-gil, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 17718 (Rep. of   KOREA)2023-07-27 有效
17醫(yī)用檢查手套國械備20230253號Koon   Seng Sdn.Bhd.PTD   16058,Kawasan Perindustrian Tangkak,JalanMuar,84900 Tangkak,Johor,Malaysia2023-07-27 變更
18醫(yī)用檢查手套國械備20230254號Koon   Seng Sdn.Bhd.PTD   16058,KawasanPerindustrian Tangkak,JalanMuar,84900 Tangkak,Johor,Malaysia2023-07-27 變更
19牙科骨粉輸送器國械備20230359號Haenaem   Co., Ltd.194,   Jisan-ro 175beon-gil, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 17718 (Rep. of   KOREA)2023-07-27 有效
20鉆針深度停止器國械備20230358號Haenaem   Co., Ltd.194,   Jisan-ro 175beon-gil, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 17718 (Rep. of   KOREA)2023-07-27 有效
21牙科成形片套裝國械備20160776號GARRISON   DENTAL SOLUTIONS L.L.C.16673   148th Ave Unit 4 Spring Lake, MI 494562023-07-27 變更
22唇頰牽開器國械備20230357號Align   Technology, Inc.Aligntech   de Mexico S. de R.L. de C.V.  Boulevard   Independencia 1951, Parque Industrial    Salvacar, Cd. Juarez Chihuahua, MEXICO 325752023-07-27 有效
23手術(shù)輔助照明燈國械備20162066號Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2023-07-26 變更
24打磨拋光清潔器具國械備20210507號Garrison   Dental Solutions LLC19,   Hayezira St., Ra’anana, Israel; Neureutstra?e 6 75210 Keltern Germany2023-07-26 變更
25打入器國械備20150259號Medos   International SARL Chemin   Blanc, 38 Le Locle, CH-2400, Switzerland2023-07-25 變更
26注射器輔助推進槍國械備20230356號Deusch   Medizintechnik GmbHBregstrasse   34, 78120 Furtwangen2023-07-25 有效
27手術(shù)刀國械備20210443號Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-07-25 變更
28替代體國械備20181711號ADIN   DENTAL IMPLANT SYSTEMS LTD.Industrial   Zone, Alon Tavor, Afula POB 1128, Afula 1811101, Israel2023-07-24 變更
29測序反應(yīng)通用試劑盒（測序法）國械備20180410號Illumina,   Inc.5200   Illumina Way, San Diego, California 92122, USA2023-07-24 變更
30測序反應(yīng)通用試劑盒（測序法）國械備20190416號Illumina,   Inc.29   Woodlands Industrial Park E1, Northtech, Singapore 7577162023-07-24 變更
31牙科用軟組織環(huán)切刀國械備20200611號//2023-07-24 變更
32牙用尺國械備20161414號MIS   Implants Technologies Ltd.Bar   Lev Industrial Park, 2015600 Israel2023-07-24 變更
33種植安裝輔助工具包國械備20190883號MIS   Implants Technologies Ltd.P.O.   Box 7 Bar Lev Industrial Park, 2015600, Israel 2023-07-24 變更
34唇頰牽開器國械備20220479號Align   Technology, Inc.Ave.   La Cuspide No.1 Del. Playas de Tijuana, TIJUANA, Baja California Mexico 225002023-07-24 變更
35組織鑷國械備20230355號BMC-PRIMA   GmbHHerrenbachstr.   17 73066 Uhingen Germany2023-07-24 有效
36牽開器國械備20230354號BMC-PRIMA   GmbHHerrenbachstr.   17 73066 Uhingen Germany2023-07-24 有效
37血紅蛋白檢測用裝載片國械備20190477號Fresenius   Kabi AGVon-Cancrin-Straβe   1, 63877 Sailauf ,  Deutschland2023-07-24 變更
38頭戴式檢查燈國械備20230353號(?)?????????   ?? ?????26? 12 R&D?? 403?2023-07-24 有效
39醫(yī)用放大鏡國械備20230352號(?)?????????   ?? ?????26? 12 R&D?? 403?2023-07-24 有效
40正畸鉗國械備20180071號Ortho   Organizers, Inc.1.Ranger   H.Q. Road Cantt, Sialkot – Pakistan；2.3232 N. Rockwell Street, Chicago, IL,   60618, United States；3.Nasir Road, Sialkot-Pakistan2023-07-21 變更
41醫(yī)用檢查手套國械備20170208號Henry   Schein Services GmbHLot   1365, Batu 17, Jalan Sungai Sembilang, Jeram, Kuala Selangor, Selangor Darul   Ehsan 45800 Malaysia2023-07-21 變更
42正畸鉗國械備20160817號Ormco   Corporation1)   1332 South Lone Hill Avenue, Glendora, California,  91740, USA;
   
    2) Circuito Sur No.31, Parque Industrial Nelson, Mexicali, B.C. C.P. 21395,   Mexico
   
    3) Calle Industrial Del Acero No.18, parque Industrial EL Vigia Mexicali,   Baja California Mexico 21397		2023-07-21 變更
43股骨干手術(shù)工具國械備20230351號SERF85   Avenue des Bruyères，69150 DECINES-CHARPIEU，F(xiàn)RANCE2023-07-21 有效
44CD28檢測試劑(流式細胞儀法)國械備20230350號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-07-20 有效
45骨測量器國械備20200173號Rebstock   Instruments GmbHIn   Weiher Weiher?cker 7 78589 D Dürbheim Germany2023-07-20 無效
46骨測量器國械備20230349號Rebstock   Instruments GmbHIn   Weiher?cker 7 78589 Dürbheim, Germany2023-07-20 有效
47CD28檢測試劑(流式細胞儀法)國械備20230348號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-07-20 有效
48瑞氏染色液   ADVIA Autoslide Modified Wright Stain國械備20151834號Siemens   Healthcare Diagnostics Inc.4481   Campus Drive, Kalamazoo, Michigan 49008 USA2023-07-20 變更
49緩沖液   ADVIA Autoslide Modified Wright Buffer國械備20151129號Siemens   Healthcare Diagnostics Inc.4481   Campus Drive, Kalamazoo, Michigan 49008, USA2023-07-20 變更
50CD28檢測試劑（流式細胞儀法）國械備20230347號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-07-20 有效
51洗板機國械備20190496號Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-07-20 變更
52洗板機國械備20190874號Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-07-20 變更
53洗板機國械備20181472號Agilent   Technologies, Inc.100   Tigan Street Highland Park Winooski, VT 05404-0998 USA2023-07-20 變更
54骨關(guān)節(jié)手術(shù)器械國械備20170306號DePuy   Mitek325   Paramount Drive Raynham, MA 02767 USA2023-07-20 變更
55干式激光成像儀國械備20230346號COLENTA   Labortechnik GmbH & Co.KGNeunkirchner   Str.117,2700 Wiener Neustadt, Austria2023-07-20 有效
56肌電導聯(lián)線國械備20210504號Natus   Manufacturing LimitedIDA   Business Park Gort Co.Galway Ireland2023-07-20 變更
57電極導聯(lián)線國械備20220096號Natus   Neurology Incorporated3150   Pleasant View Road Middleton Wisconsin 53562 USA； IDA Business Park Gort Co.   Galway Ireland； 250 Okgucheondong-ro Siheung-si Gyeongi-do 15084 Republic of   Korea2023-07-20 變更
58腦電/肌電導聯(lián)線國械備20210518號Natus   Neurology Incorporated3150   Pleasant View Road Middleton, Wisconsin 53562 USA;IDA Business Park Gort   Co.Galway Ireland.2023-07-20 變更
59口腔數(shù)字觀察儀國械備20200038號ModJaw   SAS354   Voie Magellan 73800 Sainte-Hélène-du-Lac France2023-07-20 變更
60造口袋國械備20190171號ConvaTec   Inc.Carretera   Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal, 91000 Dominican Republic.2023-07-19 變更
61橡皮障器械國械備20171011號Kentzler-Kaschner   Dental GmbHMühlgraben   36,73479 Ellwangen/Jagst,Germany2023-07-19 變更
62正畸自鎖托槽開啟器國械備20210533號GNI   Co., Ltd.5F   501, 63-12, Dongtancheomdansaneop 1-ro, Hwaseong-si, Gyeonggi-do, Republic of   Korea2023-07-19 變更
63醫(yī)用退熱貼 國械備20230345號新タック化成株式會社香川県三豊市豊中町上高野4148番地2023-07-19 有效
64 骨關(guān)節(jié)手術(shù)器械 國械備20140151號DePuy   Mitek325   Paramount Drive , Raynham, MA 02767 , USA；Puits Godet 20 NeuchatelCH-2000   Switzerland；Kibbutz GaatonKibbutz Gaaton25130 Israel2023-07-18 變更
65CD8抗體試劑（免疫組織化學）國械備20230344號Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA2023-07-18 有效
66醫(yī)用外固定支具國械備20170130號THUASNE118/120,   rue Marius Aufan BP 243 FR-92307 LEVALLOIS-PERRET; 4615 Shepard St.   Bakersfield, CA 93313;Im Steinkamp 12, 30938 Burgwedel 2023-07-18 變更
67自粘彈力繃帶國械備20161076號3M   Company601   22nd Ave. South Brookings, South Dakota, 57006, USA2023-07-17 變更
68口腔麻醉劑手動助推器國械備20220200號SEPTODONT3,   rue Jean-Jacques Rousseau B.P. 282 - Aussillon Mazamet Cedex 81207 France2023-07-17 變更
69測瓣器/測環(huán)器/持環(huán)器連接手柄國械備20230343號Medtronic,   Inc.1851   E. Deere Avenue, Santa Ana, CA 92705, USA2023-07-17 有效
70手術(shù)頭燈國械備20230342號(?)????????????   166 102? 304?(???,???????)2023-07-17 有效
71牙科種植定位器國械備20150163號Dentium   Co., Ltd.150,   Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do2023-07-17 變更
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73造口袋國械備20190931號Coloplast   A/SColoplast   Hungary KFT, Kerék utca 4, 2800 Tatabánya, Hungary2023-07-13 變更
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177矯形外科（骨科）手術(shù)器械國械備20171254號Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG2023-07-27 無效
178耳鼻喉科手術(shù)器械 國械備20171242號Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG2023-07-27 無效
179腹部外科手術(shù)器械國械備20171251號Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG2023-07-27 無效
180基礎(chǔ)外科手術(shù)器械國械備20170581號Mill   Medical Instruments B.V.Unit   801B 8/F Trend Ctr 29 Cheung Lee St Chai Wan,Hong Kong2023-07-27 無效
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187基礎(chǔ)外科手術(shù)器械國械備20180031號Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN，HONG KONG.2023-07-27 無效

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